Trial Outcomes & Findings for A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis (NCT NCT04015518)

Last Updated: 2025-10-16

Results Overview

The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \* 100%. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

152 participants

Primary outcome timeframe

week 0 (baseline) and week 16

Results posted on

2025-10-16

Participant Flow

This was a randomised, placebo-controlled, double-blind, parallel-design trial comparing 5 treatment arms over 52 weeks. Randomisation was stratified for Japan versus non-Japan. Patients who completed the treatment period without premature discontinuation and obtained an individual health benefit, per investigator judgement, could continue treatment with spesolimab in the open-label extension trial 1368-0024.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo & Spesolimab Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.	Spesolimab 'Speso Low' Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Overall Study STARTED	43	22	21	22	44
Overall Study Full Analysis Set (FAS)	43	22	21	22	44
Overall Study COMPLETED	32	19	18	17	32
Overall Study NOT COMPLETED	11	3	3	5	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo & Spesolimab Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.	Spesolimab 'Speso Low' Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Overall Study Adverse Event	6	1	1	3	3
Overall Study Lack of Efficacy	1	0	1	0	4
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Withdrawal by Subject	0	1	0	1	1
Overall Study Patient did not come for consecutive visits	0	1	0	0	0
Overall Study not willing to travel due to Covid-19	0	0	1	0	0
Overall Study Patient wants to discontinue treatment	0	0	0	1	0
Overall Study Difficult for patient to come to the hospital	0	0	0	0	1
Overall Study Pregnancy	0	0	0	0	1
Overall Study Personal reasons	1	0	0	0	1
Overall Study Withdrew consent	1	0	0	0	0
Overall Study Prostate carcinoma	1	0	0	0	0
Overall Study Could not keep appointments due to work	1	0	0	0	0

Baseline Characteristics

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo & Spesolimab n=43 Participants Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.	Spesolimab 'Speso Low' n=22 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.	Total n=152 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 10.1 • n=5 Participants	54.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	51.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	52.8 years STANDARD_DEVIATION 9.2 • n=4 Participants	53.4 years STANDARD_DEVIATION 13.0 • n=21 Participants	54.4 years STANDARD_DEVIATION 11.0 • n=10 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	27 Participants n=21 Participants	110 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants	42 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	41 Participants n=21 Participants	141 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	15 Participants n=21 Participants	60 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	26 Participants n=21 Participants	80 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants
Palmoplantar Pustulosis Area and Severity Index (PPP ASI)	27.07 Score on a scale STANDARD_DEVIATION 12.44 • n=5 Participants	23.85 Score on a scale STANDARD_DEVIATION 9.42 • n=7 Participants	23.62 Score on a scale STANDARD_DEVIATION 11.02 • n=5 Participants	26.65 Score on a scale STANDARD_DEVIATION 11.20 • n=4 Participants	24.00 Score on a scale STANDARD_DEVIATION 10.25 • n=21 Participants	25.18 Score on a scale STANDARD_DEVIATION 11.00 • n=10 Participants

PRIMARY outcome

Timeframe: week 0 (baseline) and week 16

Population: Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=20 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=20 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=41 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline	-33.6 Percentage of change in PPP ASI Interval -43.5 to -23.7	-44.2 Percentage of change in PPP ASI Interval -57.8 to -30.6	-48.3 Percentage of change in PPP ASI Interval -61.8 to -34.7	-46.2 Percentage of change in PPP ASI Interval -59.9 to -32.6	-38.9 Percentage of change in PPP ASI Interval -48.5 to -29.3

SECONDARY outcome

Timeframe: week 0 (baseline) and week 4.

Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=20 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=20 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=41 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4	-9.3 Score on a scale Interval -17.0 to -1.6	-15.4 Score on a scale Interval -26.1 to -4.8	-14.7 Score on a scale Interval -25.7 to -3.8	-12.8 Score on a scale Interval -23.5 to -2.1	-18.7 Score on a scale Interval -26.3 to -11.1

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16.

Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=20 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=20 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=41 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16	-14.7 Score on a scale Interval -22.7 to -6.7	-18.7 Score on a scale Interval -29.8 to -7.7	-13.8 Score on a scale Interval -24.8 to -2.8	-18.9 Score on a scale Interval -30.0 to -7.8	-22.4 Score on a scale Interval -30.2 to -14.6

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16.

PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=20 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=20 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=41 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16	-2.7 Score on a scale Interval -3.4 to -2.0	-3.3 Score on a scale Interval -4.3 to -2.4	-3.2 Score on a scale Interval -4.2 to -2.3	-3.5 Score on a scale Interval -4.4 to -2.5	-2.8 Score on a scale Interval -3.4 to -2.1

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16

Population: Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.

Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 50%, PPP ASI50 = 1.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=22 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)	12 Participants	7 Participants	10 Participants	12 Participants	18 Participants

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16

Population: Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.

Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 75%, PPP ASI75 = 1.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=22 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)	3 Participants	3 Participants	6 Participants	4 Participants	9 Participants

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16

Population: Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.

Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=22 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16	2 Participants	6 Participants	4 Participants	4 Participants	9 Participants

SECONDARY outcome

Timeframe: week 0 (baseline) and week 16

Population: Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.

Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=22 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16	5 Participants	7 Participants	6 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: week 0 (baseline) and week 52

The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). LS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab 'Speso Low' n=19 Participants Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=18 Participants Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=17 Participants Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=32 Participants Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline	-54.6 Percentage of change in PPP ASI Interval -65.8 to -43.3	-73.3 Percentage of change in PPP ASI Interval -87.9 to -58.6	-73.8 Percentage of change in PPP ASI Interval -89.1 to -58.6	-81.2 Percentage of change in PPP ASI Interval -96.4 to -66.1	-60.0 Percentage of change in PPP ASI Interval -70.9 to -49.2

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Spesolimab Post Placebo

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Spesolimab 'Speso Low'

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Spesolimab 'Speso Medium-low'

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Spesolimab 'Speso Medium-high'

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Spesolimab 'Speso High'

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=43 participants at risk Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab Post Placebo n=38 participants at risk Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.	Spesolimab 'Speso Low' n=22 participants at risk Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 participants at risk Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 participants at risk Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 participants at risk Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Cardiac disorders Acute myocardial infarction	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Cardiac disorders Angina unstable	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Eye disorders Retinal artery embolism	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Psychiatric disorders Bipolar disorder	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Psychiatric disorders Depression	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Vascular disorders Circulatory collapse	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo n=43 participants at risk Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.	Spesolimab Post Placebo n=38 participants at risk Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.	Spesolimab 'Speso Low' n=22 participants at risk Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-low' n=21 participants at risk Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso Medium-high' n=22 participants at risk Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.	Spesolimab 'Speso High' n=44 participants at risk Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Cardiac disorders Palpitations	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Constipation	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
General disorders Injection site erythema	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	18.2% 4/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	6.8% 3/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
General disorders Injection site pain	7.0% 3/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	14.3% 3/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
General disorders Injection site reaction	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	10.5% 4/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	23.8% 5/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	22.7% 5/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	45.5% 20/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	11.6% 5/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	7.9% 3/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 4/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Infections and infestations Rhinitis	7.0% 3/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	6.8% 3/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 4/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	14.0% 6/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	10.5% 4/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	13.6% 3/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	6.8% 3/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	18.2% 4/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 2/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pustulotic arthro-osteitis	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 2/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Nervous system disorders Headache	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	7.9% 3/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	11.4% 5/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Psychiatric disorders Insomnia	7.0% 3/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.3% 1/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	14.3% 3/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Eczema	4.7% 2/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	5.3% 2/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	27.3% 6/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.5% 2/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	9.3% 4/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	11.4% 5/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	2.3% 1/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 2/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	9.1% 2/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.5% 1/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/43 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	2.6% 1/38 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	4.8% 1/21 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	0.00% 0/22 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.	6.8% 3/44 • Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks. Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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